BIOTECH: Invitrogen gets approval for breast cancer test

Diagnostic a first for Invitrogen

By BRADLEY J. FIKES - Staff Writer | Tuesday, July 8, 2008 5:58 PM PDT ∞

CARLSBAD ---- Invitrogen Corp. said Tuesday the U.S. Food and Drug Administration has approved the company's new breast cancer test.

The test helps determine which patients are most likely to benefit from treatment with Herceptin, a drug that targets a gene involved in some breast cancers. The test will be available in mid-August.

Invitrogen sells products and provides services to academic institutions and biotech companies to help them perform biological research. Until now, Invitrogen has avoided selling products directly used on patients, such as drugs and diagnostic tests.

"It's the first product that Invitrogen has that's required a full pre-market approval," said Brett Williams, a senior director of cellular analysis at Invitrogen. The approval is required for products that can directly affect how a patient is treated, Williams said.

"It's certainly a milestone for the company," Williams said.

Williams said Spot-Light is less expensive and easier to use than competing processes.

Invitrogen's test is easier to use than existing tests and will probably sell for less, said John McCamant, editor of the Berkeley-based Medical Technology Stock Letter.

"The cost advantage is a big deal," McCamant said. "It's nice to see a little competition."

Another new breast cancer test to help determine Herceptin use, from Monogram Biosciences Inc. of South San Francisco, will be sold starting next week. The test will cost $3,350, according to an article in Tuesday's Web edition of the San Francisco Business Times. Invitrogen estimates its test will cost about $70.

Shares of Invitrogen closed Tuesday after the announcement at $40.47, up $1.80 for the day.

Invitrogen is the most highly valued publicly traded company in North County, with stock currently valued at more than $3.5 billion. It employs about 1,000 people in Carlsbad, and thousands more in other locations. Last month, Invitrogen struck a deal to buy Applied Biosystems of Foster City for an estimated $6.7 billion, 45 percent in cash and the rest in stock.

Applied Biosystems used to be a unit of Celera Group, headquartered in Norwalk, Conn. On July 1, Applied Biosystems and Celera were spun off as separate companies, Celera is not part of the purchase and will remain an independent company.

Contact staff writer Bradley J. Fikes at (760) 739-6641 or bfikes@nctimes.com.

How the test works

The test is called the Spot-Light HER2 CISH Kit. It is based on a technology called "chromagenic in situ hybridization." The test detects the status of the HER2 gene, which is overactive in 18 to 30 percent of breast cancers.

Patients with an overactive HER2 gene are suitable candidates for Herceptin, which blocks a growth-promoting protein the gene makes. The drug costs about $60,000 a year, so a test that predicts effectiveness would be of great interest to patients and insurers. Invitrogen says the test will cost about $70.

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